NCT01065987

Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed Conditions

Randomized, 2-way Crossover, Bioequivalence Study of Tizanidine Hydrochloride 4mg Tablets and Zanaflex® 4mg Tablets Administered As 1 x 4mg Tablet in Healthy Adult Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fed conditions.

Detailed description

Randomized, 2-way crossover, bioequivalence study of tizanidine Hydrochloride 4mg tablets and zanaflex® 4mg tablets administered As 1 x 4mg tablet in healthy adult subjects under fed conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tizanidine	Tizanidine HCl Tablets 4 mg

Timeline

• Start date: 2001-09-01
• Primary completion: 2001-09-01
• Completion: 2001-11-01
• First posted: 2010-02-10
• Last updated: 2010-02-10

Locations

1 site across 1 country: Canada